ID

42972

Description

A Phase II Clinical Trial of Suppression of Human Antimouse Antibody and Human Antitoxin Response to Immunotoxin LMB-1 by Rituximab; ODM derived from: https://clinicaltrials.gov/show/NCT00001805

Link

https://clinicaltrials.gov/show/NCT00001805

Keywords

Versions (2)
  1. 1/6/16 1/6/16 -
  2. 9/17/21 9/17/21 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Breast Neoplasms NCT00001805

English

Eligibility Breast Neoplasms NCT00001805

1 forms  
Criteria
Description

Criteria

must have the presence of b3 antigen on the surface of greater than 30% of the tumor cells.
Description

presence of b3 antigen

Data type

boolean

must be greater than or equal to 18 years old and be able to give informed consent.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
must have an ecog performance status of 0 or 1 and a minimum life expectancy of 3 months.
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
must have normal renal function (creatinine less than or equal to 1.4 mg/dl), sgot and sgpt less than or equal to 2.5 x of the upper limits of normal. total bilirubin less than 1.5 mg/dl; agc greater than or equal to 1.5 x 10(3) microliter; platelets greater than 100,000 per mm(3).
Description

must have normal renal function (creatinine less than or equal to 1.4 mg/dl), sgot and sgpt less than or equal to 2.5 x of the upper limits of normal. total bilirubin less than 1.5 mg/dl; agc greater than or equal to 1.5 x 10(3) microliter; platelets greater than 100,000 per mm(3).

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0005821
must have recovered from the toxic effects of prior chemotherapy or radiation therapy. at least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. at least six weeks must have elapsed since the last dose of mitomycin c and a nitrosourea.
Description

must have recovered from the toxic effects of prior chemotherapy or radiation therapy. at least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. at least six weeks must have elapsed since the last dose of mitomycin c and a nitrosourea.

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
UMLS CUI [4]
C0002475
UMLS CUI [5]
C0028210
must not have serum neutralizing antibodies to lmb-1.
Description

serum neutralizing antibodies to lmb-1

Data type

boolean

Alias
UMLS CUI [1]
C0796420
must not have positive hepatitis b surface antigen, hepatitis c antibody or hiv.
Description

hepatitis b surface antigen, hepatitis c antibody or hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019682
must not have a history of coronary artery disease, ny class ii-iv chf, arrhythmia requiring treatment and any contraindication to pressor therapy.
Description

must not have a history of coronary artery disease, ny class ii-iv chf, arrhythmia requiring treatment and any contraindication to pressor therapy.

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C1275491
UMLS CUI [3]
C0003811
must not have fev1 and fvc less than or equal to 65% of the predicted value.
Description

must not have fev1 and fvc less than or equal to 65% of the predicted value.

Data type

boolean

Alias
UMLS CUI [1]
C0748133
UMLS CUI [2]
C1287681
must not have baseline serum albumin of less than 3.0 g/dl.
Description

albumin

Data type

boolean

Alias
UMLS CUI [1]
C0201838
must not have a history of cns metastasis and/or known seizure disorders, or concurrent malignancy.
Description

must not have a history of cns metastasis and/or known seizure disorders, or concurrent malignancy.

Data type

boolean

Alias
UMLS CUI [1]
C0279130
UMLS CUI [2]
C0036572
UMLS CUI [3]
C0006826
must not have an acute bacterial infection that requires antibiotic therapy (unless infection is completely resolved).
Description

acute bacterial infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
must not have any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Description

must not have any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
must not be pregnant or breastfeeding. patients of childbearing potential must agree to use an effective method of contraception.
Description

must not be pregnant or breastfeeding. patients of childbearing potential must agree to use an effective method of contraception.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
must not have a history of allergic reaction to penicillin.
Description

allergic reaction to penicillin

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0030842
must not have lymphoma.
Description

lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0024299
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Similar models

Eligibility Breast Neoplasms NCT00001805

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
presence of b3 antigen
Item
must have the presence of b3 antigen on the surface of greater than 30% of the tumor cells.
boolean
age
Item
must be greater than or equal to 18 years old and be able to give informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
ecog performance status
Item
must have an ecog performance status of 0 or 1 and a minimum life expectancy of 3 months.
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
must have normal renal function (creatinine less than or equal to 1.4 mg/dl), sgot and sgpt less than or equal to 2.5 x of the upper limits of normal. total bilirubin less than 1.5 mg/dl; agc greater than or equal to 1.5 x 10(3) microliter; platelets greater than 100,000 per mm(3).
Item
must have normal renal function (creatinine less than or equal to 1.4 mg/dl), sgot and sgpt less than or equal to 2.5 x of the upper limits of normal. total bilirubin less than 1.5 mg/dl; agc greater than or equal to 1.5 x 10(3) microliter; platelets greater than 100,000 per mm(3).
boolean
C0201976 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0005821 (UMLS CUI [5])
must have recovered from the toxic effects of prior chemotherapy or radiation therapy. at least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. at least six weeks must have elapsed since the last dose of mitomycin c and a nitrosourea.
Item
must have recovered from the toxic effects of prior chemotherapy or radiation therapy. at least 3 weeks must have elapsed since the last dose of chemotherapy, hormonal therapy or radiation therapy. at least six weeks must have elapsed since the last dose of mitomycin c and a nitrosourea.
boolean
C0392920 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0028210 (UMLS CUI [5])
serum neutralizing antibodies to lmb-1
Item
must not have serum neutralizing antibodies to lmb-1.
boolean
C0796420 (UMLS CUI [1])
hepatitis b surface antigen, hepatitis c antibody or hiv
Item
must not have positive hepatitis b surface antigen, hepatitis c antibody or hiv.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
must not have a history of coronary artery disease, ny class ii-iv chf, arrhythmia requiring treatment and any contraindication to pressor therapy.
Item
must not have a history of coronary artery disease, ny class ii-iv chf, arrhythmia requiring treatment and any contraindication to pressor therapy.
boolean
C1956346 (UMLS CUI [1])
C1275491 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
must not have fev1 and fvc less than or equal to 65% of the predicted value.
Item
must not have fev1 and fvc less than or equal to 65% of the predicted value.
boolean
C0748133 (UMLS CUI [1])
C1287681 (UMLS CUI [2])
albumin
Item
must not have baseline serum albumin of less than 3.0 g/dl.
boolean
C0201838 (UMLS CUI [1])
must not have a history of cns metastasis and/or known seizure disorders, or concurrent malignancy.
Item
must not have a history of cns metastasis and/or known seizure disorders, or concurrent malignancy.
boolean
C0279130 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
acute bacterial infection
Item
must not have an acute bacterial infection that requires antibiotic therapy (unless infection is completely resolved).
boolean
C0009450 (UMLS CUI [1])
must not have any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
Item
must not have any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
must not be pregnant or breastfeeding. patients of childbearing potential must agree to use an effective method of contraception.
Item
must not be pregnant or breastfeeding. patients of childbearing potential must agree to use an effective method of contraception.
boolean
C0032961 (UMLS CUI [1])
allergic reaction to penicillin
Item
must not have a history of allergic reaction to penicillin.
boolean
C0020517 (UMLS CUI [1,1])
C0030842 (UMLS CUI [1,2])
lymphoma
Item
must not have lymphoma.
boolean
C0024299 (UMLS CUI [1])
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